Safe Step Act: does it undermine step therapy?

Drug expenditure in the United States has continued to increase unsustainably; the specialty of dermatology has been particularly affected. Resources are limited - someone has to make decisions about what treatments will be covered and how they will be reimbursed. Step therapy is a cost-control method used by insurers to encourage the use of the most cost-effective treatments before more expensive options are attempted. However, a rigid step therapy policy can be problematic when protocols are out of date, or delay necessary treatment leading to unnecessary suffering, increased morbidity, and overall cost. To address some of these concerns, the proposed Safe Step Act (S. 2546 and H.R. 2279) attempts to create a requirement that insurers provide a transparent, expeditious exceptions process for step therapy protocols. Increased flexibility in this process will allow for the unique circumstances of individual patients and improve access to expensive drugs for special cases. However, this bill may be exploited, further weakening insurers' ability to negotiate on cost. We should be cautious about measures that reduce the effectiveness of this tool, particularly if we, as a society, aim to expand access to basic care to all Americans.